Trials
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Randomized Controlled Trial Multicenter Study
Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II trial): study protocol for a randomized controlled trial.
Hydrogen gas inhalation (HI) improved survival and neurological outcomes in an animal model of post-cardiac arrest syndrome (PCAS). The feasibility and safety of HI for patients with PCAS was confirmed in a pilot study. The objective of this study is to evaluate the efficacy of HI for patients with PCAS. ⋯ The first multicenter randomized trial is underway to confirm the efficacy of HI on neurological outcomes in comatose out-of-hospital cardiac arrest survivors. Our study has the potential to address HI as an appealing and innovative therapeutic strategy for PCAS in combination with TTM.
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Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma. ⋯ This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.
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Randomized Controlled Trial Pragmatic Clinical Trial
Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial.
Effective yet practical strategies are needed to increase engagement in HIV treatment and prevention services, particularly in high-HIV-prevalence hotspots. We designed a community-based intervention called "Health Scouts" to promote uptake and adherence to HIV services in a highly HIV-prevalent fishing community in Rakai, Uganda. Using a situated Information, Motivation, and Behavioral skills theory framework, the intervention consists of community health workers, called Health Scouts, who use motivational interviewing strategies and mobile health tools to promote engagement in HIV treatment and prevention services. ⋯ HIV treatment and prevention service engagement remains suboptimal in HIV hotspots. New, community-based implementation approaches are needed. If found to be effective in this trial, the Health Scout intervention may be an important component of a comprehensive HIV response.
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Randomized Controlled Trial
Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial.
Obstructive sleep apnea (OSA) occurs due to sleep-induced upper airway muscle relaxation resulting in increased pharyngeal collapsibility. Clinical trials have shown a favorable effect of exercise training on OSA severity in middle-aged adults. Aging is characterized by motor-unit loss. Force training may affect the whole body muscle tone. We hypothesize that interventions increasing muscle strength might propagate to motor units at the abductor pharyngeal muscles, reducing collapsibility and, hence, sleep apnea severity in elderly patients with obstructive sleep apnea. ⋯ The high prevalence of obstructive sleep apnea in elderly people is a public health issue. OSA is a recognized cause of cardiovascular disease and reduces quality of life due to sleepiness and fatigue. Exercise is a low-cost intervention that could help to detain the trend towards age-dependent loss of pharyngeal motor units and progressive severity of obstructive sleep apnea. Home-based strength exercises may represent a more practical approach than aerobic exercise for elderly patients. If the results confirm our hypothesis, further research on the clinical application of our findings will be warranted.
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Randomized Controlled Trial Multicenter Study Comparative Study
A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission.
There is concern that existing models of acute hospital care will become unworkable as the health service admits an increasing number of frail older people with complex health needs, and that there is inadequate evidence to guide the planning of acute hospital level services. We aim to evaluate whether geriatrician-led admission avoidance to hospital at home is an effective alternative to hospital admission. ⋯ Health systems around the world are examining how to provide acute hospital-level care to older adults in greater numbers with a fixed or shrinking hospital resource. This trial is the first large multi-site randomised trial of geriatrician-led admission avoidance hospital at home, and will provide evidence on alternative models of healthcare for older people who require hospital admission.